Regulatory Affairs Specialist

About the role

The Regulatory Affairs Specialist will support the execution of regulatory activities for AbbVie’s product portfolio in Colombia, ensuring compliance with local regulations, approved plans, and company policies. The role involves preparing and maintaining regulatory submissions, managing product licenses, and collaborating with cross‑functional teams to minimize supply interruptions.

Key responsibilities

• Prepare, submit, and follow up on regulatory applications, including new marketing authorizations, variations, renewals, and notifications.
• Maintain product licenses and regulatory documentation in line with local requirements and internal procedures.
• Interact with local regulatory authorities, escalating complex issues to senior team members when needed.
• Provide accurate responses to health authority questions and track post‑approval commitments.
• Review promotional and non‑promotional materials for regulatory compliance.
• Support labeling, prescribing information, and packaging updates to ensure alignment with approved information.
• Maintain regulatory databases, trackers, and submission records accurately and on time.
• Monitor regulatory updates, communicate changes to the team, and assess potential impact.

Required profile

• University degree in Pharmacy or a related health‑science field.
• 2‑3 years of experience in Regulatory Affairs within the pharmaceutical industry.
• Intermediate English proficiency (B1‑B2) for reading regulatory documents and participating in meetings.
• Strong attention to detail when preparing and reviewing regulatory documentation.
• Ability to collaborate effectively with cross‑functional teams and manage multiple activities.

Required skills

• Regulatory databases
• Electronic document management systems